Potential Loss of Device Functionality

Amplia, Claria, Compia, and Viva CRT-D, and Evera and Visia ICD Original Date of Advisory:
January 2018

Product

A subset of 48 Medtronic Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs) underwent a specific sequence of manufacturing processes that could result in an unexpected loss of device functionality, including high-voltage therapy. You may use the "Search for Information by Serial Number" tool on home page of this web site to determine if a specific device is affected. No other Medtronic devices are included in this advisory.

Advisory

These 48 devices were sent through a manufacturing sequence that introduced the potential for internal arcing during highvoltage charging, leading to the immediate and permanent loss of device functionality. Through 12 January 2018, Medtronic has confirmed one (1) implanted device failure resulting in loss of high-voltage therapy related to this issue, where the patient was rescued with external defibrillation.

Due to the nature of this issue, it is not possible to identify which of these 48 devices may fail or when they may fail. Further, we cannot predict how many high-voltage charges can occur prior to a potential failure. Based on testing of a limited number of available devices that underwent this manufacturing sequence, this failure was observed during high-voltage cycle testing to battery depletion in 23% of these devices, with failure observed within the first two (2) high-voltage charges in 7.7% of the tested devices. Successful delivery of previous high-voltage therapy does not guarantee future performance.

Patient Management Recommendations

We realize that each patient requires unique clinical considerations. In consultation with Medtronic’s Independent Physician Quality Panel (IPQP), Medtronic provides the following recommendation:

Prophylactic device replacement should be strongly considered for patients who have been implanted with one of the devices in the affected subset.

Status Update

Within the 48 devices, there has been 1 confirmed failure (2.1%) through October 12, 2018. An estimated 7 devices remain active.

Initial Affected Population

Number of Confirmed Advisory Related Events

Estimated Remaining Active Population

Current Malfunction Rate (confirmed malfunctions over total population)